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Predicting Outcomes in Atrial Fibrillation and Heart Failure

Predicting Outcomes in Atrial Fibrillation and Heart Failure

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06417242
Acronym
PrOAF-HF
Enrollment
80
Registered
2024-05-16
Start date
2024-05-31
Completion date
2026-10-31
Last updated
2024-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Heart Failure

Keywords

ablation, atrial fibrillation, AF, heart failure, HF, rhythm control

Brief summary

PrOAF-HF will aim to test if rhythm control delivered through catheter ablation in patients in whom it is not clear whether atrial fibrillation or heart failure were the first disease results in a greater improvement in left ventricular ejection fraction (LVEF) compared with patients where heart failure was diagnosed first with no evidence of AF.

Detailed description

Heart failure is a chronic disease affecting half a million patients in the UK. Up to 40% of patients with heart failure also suffer from atrial fibrillation. A subgroup of patients with atrial fibrillation and heart failure have tachycardia induced cardiomyopathy and benefit from significant improvement of the left ventricular function with restoration of sinus rhythm. Currently those patients can only be identified based on their response to treatment. Investigators aim to improve the treatment of AF-HF patients. The group will develop a robust modelling framework for simulating the hearts of AF-HF patients' hearts to predict patients' response to therapy and infer patient history. This modelling framework will enable integration of predictive simulations into clinical study design where the inferred initiating disease and predicted patient response to therapy are tested for selecting either rate or rhythm control in AF-HF patients. The primary objective is to test if rhythm control delivered through catheter ablation in patients where either the index disease is unclear or where AF was diagnosed prior to the onset of HF improves LVEF more than in patients where HF was diagnosed first with no evidence of AF. The secondary objectives are to examine whether the ability to terminate AF during pulmonary vein isolation is influenced by the identified index disease and to determine whether the identified index disease affects AF recurrence rate at 6 months and/or burden post ablation. This study will also identify whether the index disease affects pressure measurements as predictors of change in ejection fraction, hospitalisation, and death rates during the follow up period. This will be a non-interventional cohort study. Routinely acquired clinical data collected during pre-procedure work up will be accessed for research purposes including: 24-48 hour ambulatory (Holter) monitoring, electrocardiograph (ECG) in AF and in sinus rhythm if available; echocardiography, and clinical history and examination details. Additionally, an atrial cardiac magnetic resonance imaging (MRI) scan will be performed including assessment of atrial structure, function, fibrosis and epicardial fat burden. Symptom questionnaires will be performed During the ablation procedure, additional time will be taken to perform electrophysiological assessment in all four chambers of the heart.

Interventions

None listed

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Symptomatic persistent AF * LVEF ≤40% prior to commencement of treatment * NYHA class ≥2 * Patient must have been commenced on guideline directed medical therapy (GDMT) * Patient planning to proceed to radiofrequency atrial fibrillation ablation * Age 18-80 years * Able and willing to provide written informed consent

Exclusion criteria

* Any clinical contra-indication to ablation * Any disease limiting life expectancy to \<1 year * Potential participant currently pregnant or breast feeding * Contraindication to MRI * Paroxysmal or permanent AF * Unable to understand verbal or written explanations given in English

Design outcomes

Primary

MeasureTime frameDescription
Change in LVEF6 months post ablationChange in left ventricular ejection fraction measured on echocardiography

Secondary

MeasureTime frameDescription
AF recurrence6 months post ablationPresence of AF
Termination of AF during the procedureIntraproceduralTermination of AF during the ablation procedure
Hospitalization6 monthsHospitalization for any reason
Immediate change in LVEFImmediately post procedureChange in left ventricular ejection fraction on echocardiography
Pressure measurements as predictors of change in LVEFIntraprocedural measurements - change in LVEF as aboveInvasive measurements of all four chambers pressure changes during the ablation
Change in atrial fibrillation burden6 months post ablationChange in atrial fibrillation burden assessed on a continuous Holter monitor
Change in symptoms6 months post ablationChange in quality of lide questionnaire scores
Death6 monthsDeath of any cause and cardiovascular death

Contacts

Primary ContactMagdalena Klis, MD
magda.klis@kcl.ac.uk02071887188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026